SUN HERBAL PTY LTD
⚠️ Moderate Risk
FEI: 3012954137 • Kingsgrove, New South Wales • AUSTRALIA
FEI Number
3012954137
Location
Kingsgrove, New South Wales
Country
AUSTRALIAAddress
U 5 25 Garema Cct, , Kingsgrove, New South Wales, Australia
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
How is this score calculated?
Proprietary Algorithm
- 40% Violation Severity — AI-assessed (1-10)
- 30% Refusal Volume — Logarithmic scale
- 20% Recency — Decays over 5 years
- 10% Frequency — Refusals per year
© ImportRefusal.com Original Analysis
Violation Summary
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
NCONTACT
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.
Refusal History
Frequently Asked Questions
What is SUN HERBAL PTY LTD's FDA import refusal history?
SUN HERBAL PTY LTD (FEI: 3012954137) has 1 FDA import refusal record(s) in our database, spanning from 11/30/2016 to 11/30/2016.
What is an FEI number?
FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. SUN HERBAL PTY LTD's FEI number is 3012954137.
What types of violations has SUN HERBAL PTY LTD received?
SUN HERBAL PTY LTD has been cited for 2 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.
Where does this information about SUN HERBAL PTY LTD come from?
All FDA import refusal data for SUN HERBAL PTY LTD is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.
Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.